DOCSLIB.ORG

Furthering Public Health Security: Project Bioshield Joint Hearing

Total Page：16

File Type：pdf, Size：1020Kb

Download full-text PDF Read full-text
Furthering Public Health Security: Project Bioshield Joint Hearing FURTHERING PUBLIC HEALTH SECURITY: PROJECT BIOSHIELD JOINT HEARING BEFORE THE SUBCOMMITTEE ON HEALTH OF THE COMMITTEE ON ENERGY AND COMMERCE AND THE SUBCOMMITTEE ON EMERGENCY PREPAREDNESS AND RESPONSE OF THE SELECT COMMITTEE ON HOMELAND SECURITY HOUSE OF REPRESENTATIVES ONE HUNDRED EIGHTH CONGRESS FIRST SESSION MARCH 27, 2003 Committee on Energy and Commerce Serial No. 108–11 Select Committee on Homeland Security Serial No. 108–1 Printed for the use of the Committee on Energy and Commerce ( Available via the World Wide Web: http://www.access.gpo.gov/congress/house U.S. GOVERNMENT PRINTING OFFICE 87–480PS WASHINGTON : 2003 For sale by the Superintendent of Documents, U.S. Government Printing Office Internet: bookstore.gpo.gov Phone: toll free (866) 512–1800; DC area (202) 512–1800 Fax: (202) 512–2250 Mail: Stop SSOP, Washington, DC 20402–0001 VerDate 11-MAY-2000 11:01 Jun 19, 2003 Jkt 000000 PO 00000 Frm 00001 Fmt 5011 Sfmt 5011 87480.TXT HCOM1 PsN: HCOM1 VerDate 11-MAY-2000 11:01 Jun 19, 2003 Jkt 000000 PO 00000 Frm 00002 Fmt 5011 Sfmt 5011 87480.TXT HCOM1 PsN: HCOM1 COMMITTEE ON ENERGY AND COMMERCE W.J. ‘‘BILLY’’ TAUZIN, Louisiana, Chairman MICHAEL BILIRAKIS, Florida JOHN D. DINGELL, Michigan JOE BARTON, Texas Ranking Member FRED UPTON, Michigan HENRY A. WAXMAN, California CLIFF STEARNS, Florida EDWARD J. MARKEY, Massachusetts PAUL E. GILLMOR, Ohio RALPH M. HALL, Texas JAMES C. GREENWOOD, Pennsylvania RICK BOUCHER, Virginia CHRISTOPHER COX, California EDOLPHUS TOWNS, New York NATHAN DEAL, Georgia FRANK PALLONE, Jr., New Jersey RICHARD BURR, North Carolina SHERROD BROWN, Ohio Vice Chairman BART GORDON, Tennessee ED WHITFIELD, Kentucky PETER DEUTSCH, Florida CHARLIE NORWOOD, Georgia BOBBY L. RUSH, Illinois BARBARA CUBIN, Wyoming ANNA G. ESHOO, California JOHN SHIMKUS, Illinois BART STUPAK, Michigan HEATHER WILSON, New Mexico ELIOT L. ENGEL, New York JOHN B. SHADEGG, Arizona ALBERT R. WYNN, Maryland CHARLES W. ‘‘CHIP’’ PICKERING, GENE GREEN, Texas Mississippi KAREN MCCARTHY, Missouri VITO FOSSELLA, New York TED STRICKLAND, Ohio ROY BLUNT, Missouri DIANA DEGETTE, Colorado STEVE BUYER, Indiana LOIS CAPPS, California GEORGE RADANOVICH, California MICHAEL F. DOYLE, Pennsylvania CHARLES F. BASS, New Hampshire CHRISTOPHER JOHN, Louisiana JOSEPH R. PITTS, Pennsylvania JIM DAVIS, Florida MARY BONO, California THOMAS H. ALLEN, Maine GREG WALDEN, Oregon JANICE D. SCHAKOWSKY, Illinois LEE TERRY, Nebraska HILDA L. SOLIS, California ERNIE FLETCHER, Kentucky MIKE FERGUSON, New Jersey MIKE ROGERS, Michigan DARRELL E. ISSA, California C.L. ‘‘BUTCH’’ OTTER, Idaho DAVID V. MARVENTANO, Staff Director JAMES D. BARNETTE, General Counsel REID P.F. STUNTZ, Minority Staff Director and Chief Counsel SUBCOMMITTEE ON HEALTH MICHAEL BILIRAKIS, Florida, Chairman JOE BARTON, Texas SHERROD BROWN, Ohio FRED UPTON, Michigan Ranking Member JAMES C. GREENWOOD, Pennsylvania HENRY A. WAXMAN, California NATHAN DEAL, Georgia RALPH M. HALL, Texas RICHARD BURR, North Carolina EDOLPHUS TOWNS, New York ED WHITFIELD, Kentucky FRANK PALLONE, Jr., New Jersey CHARLIE NORWOOD, Georgia ANNA G. ESHOO, California Vice Chairman BART STUPAK, Michigan BARBARA CUBIN, Wyoming ELIOT L. ENGEL, New York HEATHER WILSON, New Mexico GENE GREEN, Texas JOHN B. SHADEGG, Arizona TED STRICKLAND, Ohio CHARLES W. ‘‘CHIP’’ PICKERING, LOIS CAPPS, California Mississippi BART GORDON, Tennessee STEVE BUYER, Indiana DIANA DEGETTE, Colorado JOSEPH R. PITTS, Pennsylvania CHRISTOPHER JOHN, Louisiana ERNIE FLETCHER, Kentucky JOHN D. DINGELL, Michigan, MIKE FERGUSON, New Jersey (Ex Officio) MIKE ROGERS, Michigan W.J. ‘‘BILLY’’ TAUZIN, Louisiana (Ex Officio) (II) VerDate 11-MAY-2000 11:01 Jun 19, 2003 Jkt 000000 PO 00000 Frm 00003 Fmt 6011 Sfmt 0486 87480.TXT HCOM1 PsN: HCOM1 SELECT COMMITTEE ON HOMELAND SECURITY CHRISTOPHER COX, California, Chairman JENNIFER DUNN, Washington JIM TURNER, Texas BILL YOUNG, Florida BENNIE G. THOMPSON, Mississippi DON YOUNG, Alaska LORETTA SANCHEZ, California JAMES SENSENBRENNER, Wisconsin EDWARD J. MARKEY, Massachusetts W.J. ‘‘BILLY’’ TAUZIN, Louisiana NORMAN D. DICKS, Washington DAVID DREIER, California BARNEY FRANK, Massachusetts DUNCAN HUNTER, California JANE HARMAN, California HAROLD ROGERS, Kentucky BENJAMIN L. CARDIN, Maryland SHERWOOD BOEHLERT, New York LOUISE McINTOSH Slaughter, New York LAMAR S. SMITH, Texas PETER A. DeFAZIO, Oregon CURT WELDON, Pennsylvania NITA M. LOWEY, New York CHRISTOPHER SHAYS, Connecticut ROBERT E. ANDREWS, New Jersey PORTER J. GOSS, Florida ElEANOR HOLMES NORTON, District of DAVE CAMP, Michigan Columbia MARIO DIAZ-BALART, Florida ZOE LOFGREN, California BOB GOODLATTE, Virginia KAREN McCARTHY, Missouri ERNEST J. ISTOOK, Oklahoma SHEILA JACKSON-LEE, Texas PETER T. KING, New York BILL PASCRELL, Jr., North Carolina JOHN LINDER, Georgia DONNA M. CHRISTENSEN, U.S.V.I. JOHN SHADEGG, Arizona BOB ETHERIDGE, North Carolina MARK E. SOUDER, Indiana CHARLES A. GONZALEZ, Texas MAC THORNBERRY, Texas KEN LUCAS, Kentucky JIM GIBBONS, Nevada JAMES R. LANGEVIN, Rhode Island KAY GRANGER, Texas KENDRICK B. MEEK, Florida PETE SESSIONS, Texas JOHN E. SWEENEY, New York SUBCOMMITTEE ON EMERGENCY PREPAREDNESS AND RESPONSE JOHN B. SHADEGG, Arizona, Chairman CURT WELDON, Pennsylvania BENNIE G. THOMPSON, Mississippi Vice Chairman JANE HARMAN, California W.J. ‘‘BILLY’’ TAUZIN, Louisiana BENJAMIN L. CARDIN, Maryland CHRISTOPHER SHAYS, Connecticut PETER A. DEFAZIO, Oregon DAVE CAMP, Michigan NITA M. LOWEY, New York MARIO DIAZ-BALART, Florida ELEANOR HOLMES NORTON, District of PETER T. KING, New York Columbia MARK E. SOUDER, Indiana BILL PASCRELL, Jr., North Carolina MAC THORNBERRY, Texas DONNA M. CHRISTENSEN, Virgin Islands JIM GIBBONS, Nevada BOB ETHERIDGE, North Carolina KAY GRANGER, Texas KEN LUCAS, Kentucky PETE SESSIONS, Texas JIM TURNER, Texas JENNIFER DUNN, Washington CHRISTOPHER COX, California (III) 2 VerDate 11-MAY-2000 11:01 Jun 19, 2003 Jkt 000000 PO 00000 Frm 00004 Fmt 0486 Sfmt 0486 87480.TXT HCOM1 PsN: HCOM1 C O N T E N T S Page Testimony of: Baker, James, Jr., Ruth Dow Doan Professor, Director, Center for Biologi- cal Nanotechnology ....................................................................................... 49 Friedman, Michael A., Chief Medical Officer for Biomedical Preparedness, PhRMA ........................................................................................................... 57 Noble, Gary, Johnson & Johnson .................................................................... 64 Read, J. Leighton, Biotechnology Industry Organization ............................. 51 Thompson, Hon. Tommy G., Secretary, Department of Health and Human Services; accompanied by Anthony Fauci, National Institutes of Health 13 Material submitted for the record by: Baker, James, Jr., Ruth Dow Doan Professor, Director, Center for Biologi- cal Nanotechnology: Letter dated April 25, 2003, to Hon. Michael Bilirakis and Hon. John B. Shadegg, enclosing response for the record ........................... 94 Letter dated April 25, 2003, to Hon. John D. Dingell and Hon. Sherrod Brown, enclosing response for the record .............................. 97 Bowdish, Katherine, President and Founder, Alexion Antiboby Tech- nologies, Inc., prepared statement of .......................................................... 82 Friedman, Michael A., Chief Medical Officer for Biomedical Preparedness, PhRMA, letter dated May 5, 2003, enclosing response for the record ..... 100 Noble, Gary, Johnson & Johnson, response for the record ........................... 88 Read, J. Leighton, Biotechnology Industry Organization, response for the record ............................................................................................................. 84 Thompson, Hon. Tommy G., Secretary, Department of Health and Human Services, response for the record ................................................................. 105 (V) 3 VerDate 11-MAY-2000 11:01 Jun 19, 2003 Jkt 000000 PO 00000 Frm 00005 Fmt 0486 Sfmt 0486 87480.TXT HCOM1 PsN: HCOM1 VerDate 11-MAY-2000 11:01 Jun 19, 2003 Jkt 000000 PO 00000 Frm 00006 Fmt 0486 Sfmt 0486 87480.TXT HCOM1 PsN: HCOM1 FURTHERING PUBLIC HEALTH SECURITY: PROJECT BIOSHIELD THURSDAY, MARCH 27, 2003 HOUSE OF REPRESENTATIVES, COMMITTEE ON ENERGY AND COMMERCE, SUBCOMMITTEE ON HEALTH, JOINT WITH THE SELECT COMMITTEE ON HOMELAND SECU- RITY, SUBCOMMITTEE ON EMERGENCY PREPAREDNESS AND RESPONSE Washington, DC. The subcommittee met, pursuant to notice, at 9:30 a.m., in room 2123, Rayburn House Office Building, Hon. Michael Bilirakis (chairman) presiding. Members present from the Subcommittee on Health: Representa- tives Bilirakis, Greenwood, Burr, Norwood, Wilson, Ferguson, Rog- ers, Tauzin (ex officio), Brown, Waxman, Eshoo, Stupak, Green, Capps, and Dingell (ex officio). Members present from the Subcommittee on Emergency Pre- paredness and Response: Representatives Shadegg, Weldon, Tau- zin, Shays, Camp, Diaz-Balart, King, Souder, Thornberry, Gibbons, Granger, Sessions, Cox, Thompson, Harman, Cardin, DeFazio, Lowey, Norton, Pascrell, Christensen, Etheridge, Lucas and Turn- er. Also Present: Representative Dunn. Staff present: Brent Del Monte, majority counsel; Steve Tilton, health policy coordinator; Eugenia Edwards, legislative clerk; John Ford, minority counsel; and Jessica McNiece, minority staff assist- ant. Mr. BILIRAKIS. Would everybody please take their seats. Good morning. I do wish to announce to the members that Secretary Thompson, who is the first panel, has to leave by 11:30 to 11:45 at the latest. So I would very much appreciate, on behalf
Load more

Recommended publications
  • GAO-09-878R Project Bioshield Act: HHS Has Supported Development
    United States Government Accountability Office Washington, DC 20548 July 24, 2009 Congressional Committees Subject: Project BioShield Act: HHS Has Supported Development, Procurement, and Emergency Use of Medical Countermeasures to Address Health Threats This report formally transmits the attached briefing in response to section 247d-6c of title 42 of the United States Code. (See the enclosure.) The statute required the Comptroller General to examine the Department of Health and Human Services’ (HHS) support for the development and procurement of and authority for the emergency use of medical countermeasures to address chemical, biological, radiological, and nuclear threats to public health, and provide the results to the congressional committees by July 21, 2009.1 HHS determines priorities for medical countermeasure procurement based on those chemical, biological, radiological, and nuclear agents that have been identified by the Department of Homeland Security as posing a material threat to the U.S. population that could affect national security. We provided the briefing to staff of your committees to satisfy the mandate reporting requirement on July 20, 2009, and July 21, 2009. – – – – – We are sending copies of this report to the Secretary of HHS, the Secretary of Homeland Security, and other interested parties. In addition, the report will be available at no charge on the GAO Web site at http://www.gao.gov. If you or your staff have any questions regarding this report, please contact me at (202) 512- 7114 or [email protected]. Contact points for our Offices of Congressional Relations and Public Affairs may be found on the last page of this report.
    [Show full text]
  • Project Bioshield Act of 2004
    PUBLIC LAW 108–276—JULY 21, 2004 118 STAT. 835 Public Law 108–276 108th Congress An Act To amend the Public Health Service Act to provide protections and countermeasures against chemical, radiological, or nuclear agents that may be used in a terrorist attack against the United States by giving the National Institutes of Health July 21, 2004 contracting flexibility, infrastructure improvements, and expediting the scientific [S. 15] peer review process, and streamlining the Food and Drug Administration approval process of countermeasures. Be it enacted by the Senate and House of Representatives of the United States of America in Congress assembled, Project BioShield Act of 2004. SECTION 1. SHORT TITLE. 42 USC 201 note. This Act may be cited as the ‘‘Project BioShield Act of 2004’’. SEC. 2. BIOMEDICAL COUNTERMEASURE RESEARCH AND DEVELOP- MENT—AUTHORITIES. (a) IN GENERAL.—Part B of title III of the Public Health Service Act (42 U.S.C. 243 et seq.) is amended by inserting after section 319F the following section: ‘‘SEC. 319F–1. AUTHORITY FOR USE OF CERTAIN PROCEDURES 42 USC 247d–6a. REGARDING QUALIFIED COUNTERMEASURE RESEARCH AND DEVELOPMENT ACTIVITIES. ‘‘(a) IN GENERAL.— ‘‘(1) AUTHORITY.—In conducting and supporting research and development activities regarding countermeasures under section 319F(h), the Secretary may conduct and support such activities in accordance with this section and, in consultation with the Director of the National Institutes of Health, as part of the program under section 446, if the activities concern qualified countermeasures. ‘‘(2) QUALIFIED COUNTERMEASURE.—For purposes of this section, the term ‘qualified countermeasure’ means a drug (as that term is defined by section 201(g)(1) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
    [Show full text]
  • Biosecurity: a Comprehensive Action Plan Center for American Progress
    Center for American Progress Biosecurity A Comprehensive Action Plan Andrew J. Grotto Jonathan B. Tucker Progressive Ideas for a Strong, Just, and Free America Biosecurity: A Comprehensive Action Plan Center for American Progress Biosecurity A Comprehensive Action Plan Andrew J. Grotto and Jonathan B. Tucker June 2006 After Guantanamo: A Special Tribunal for International Terrorist Suspects 1 Biosecurity: A Comprehensive Action Plan Center for American Progress Table of Contents EXECUTIVE SUMMARY i BIOLOGICAL THREATS FACING THE UNITED STATES 1 PREVENTING BIO-CATASTROPHES: THE NEED FOR A GLOBAL APPROACH 9 PREVENTING THE MISUSE OF THE LIFE SCIENCES 9 RECOMMENDATIONS STRENGTHENING BIOLOGICAL DISARMAMENT MEASURES 14 RECOMMENDATIONS 8 CONTAINING DISEASE OUTBREAKS: AN INTEGRATED PUBLIC HEALTH STRATEGY 21 TIMELY DETECTION OF OUTBREAKS 22 RECOMMENDATIONS 0 RAPID CONTAINMENT OF OUTBREAKS 32 RECOMMENDATIONS 5 DEFENDING AGAINST BIOLOGICAL THREATS: AN INTEGRATED RESEARCH STRATEGY 37 REFORMING THE DRUG DEVELOPMENT PROCESS 38 RECOMMENDATIONS 41 RATIONALIZING BIODEFENSE SPENDING 42 RECOMMENDATIONS 44 GLOSSARY 47 Biosecurity: A Comprehensive Action Plan ACKNOWLEDGMENTS The authors are deeply grateful to the following individuals for their valuable comments and criticisms on earlier drafts of this report: Bob Boorstin, Joseph Cirincione, P. J. Crowley, Richard Ebright, Gerald L. Epstein, Trevor Findlay, Brian Finlay, Elisa D. Harris, David Heyman, Ajey Lele, Dan Matro, Caitriona McLeish, Jonathan Moreno, Peter Ogden, Alan Pearson, Michael Schiffer, Laura Segal, and Bradley Smith. 4 Center for American Progress Executive Summary iological weapons and infectious diseases share several fundamental characteristics that the United States can leverage to counter both Bof these threats more effectively. Both a bioweapons attack and a natural pandemic, such as avian flu, can be detected in similar ways, and the effectiveness of any response to an outbreak of infectious disease, whether natural or caused deliberately by terrorists, hinges on the strength of the U.S.
    [Show full text]
  • The Project Bioshield Act: Issues for the 112Th Congress
    The Project BioShield Act: Issues for the 112th Congress Frank Gottron Specialist in Science and Technology Policy March 13, 2012 Congressional Research Service 7-5700 www.crs.gov R42349 CRS Report for Congress Prepared for Members and Committees of Congress The Project BioShield Act: Issues for the 112th Congress Summary In 2004, Congress passed the Project BioShield Act (P.L. 108-276) to provide the federal government with new authorities related to the development, procurement, and use of medical countermeasures against chemical, biological, radiological, and nuclear (CBRN) terrorism agents. As the expiration of some of these authorities approaches, Congress is considering whether these authorities have sufficiently contributed to national preparedness to merit extension. The Project BioShield Act provides three main authorities: (1) guaranteeing a federal market for new CBRN medical countermeasures, (2) permitting emergency use of countermeasures that are either unapproved or have not been approved for the intended emergency use, and (3) relaxing regulatory requirements for some CBRN terrorism-related spending. The Department of Health and Human Services (HHS) has used each of these authorities. The HHS obligated approximately $2.5 billion to guarantee a government market for countermeasures against anthrax, botulism, radiation, and smallpox. The HHS allowed the emergency use of several unapproved products, including during the 2009 H1N1 influenza pandemic. The HHS used expedited review authorities to approve contracts and grants related to CBRN countermeasure research and development. The Department of Homeland Security (DHS) Appropriations Act, 2004 (P.L. 108-90) advance- appropriated $5.593 billion to acquire CBRN countermeasures through Project BioShield for FY2004-FY2013. Through FY2012, subsequent Congresses have removed $1.876 billion from this account through rescissions and transfers, more than one-third of the advance appropriation.
    [Show full text]
  • Project Bioshield Act Fact Sheet
    ASTHO LEGAL PREPAREDNESS SERIES EMERGENCY USE AUTHORIZATION TOOLKIT Project BioShield Act Fact Sheet Overview With the anthrax and other terrorist attacks of 2001, the federal government determined that it would need new medical countermeasures, such as diagnostic tests, drugs, and vaccines, to respond to an attack using chemical, biological, radiological, or nuclear (CBRN) agents.1 The lack of a significant commercial market for CBRN countermeasures was identified as a reason for the dearth of such countermeasures.1 Since diseases and conditions caused by CBRN agents occur infrequently, the private sector did not have an economic incentive to invest the millions of dollars necessary to research and develop such measures.1 The Project BioShield Act of 20042 was enacted to accelerate the research, development, purchase, and availability of effective medical products against CBRN agents.3 Project BioShield provided the government with the authority and funding to develop, acquire, stockpile, and distribute the medical products needed to protect the United States against weapons of mass destruction.3 Note: As of March 2012, Congress is in the process of reauthorizing the Pandemic and All-Hazards Preparedness Act (PAHPA), which may impact some provisions of the Project BioShield Act. Please see ASTHO EUA Current Issues Winter 2012 for more information about reauthorization and its potential impact on EUAs and related issues. What the Law Does The Project BioShield Act authorizes expedited procurement, streamlined personnel appointments, expedited peer review, biomedical countermeasures procurement, emergency use of medical countermeasures, and other biodefense activities. Liability Protections The Project BioShield Act does not contain any explicit immunity or other liability protections.
    [Show full text]
  • Failures of Project Bioshield & Congressional Attempts to Remedy It
    DePaul Journal of Health Care Law Volume 10 Issue 3 Spring 2007 Article 8 October 2015 Failures of Project BioShield & Congressional Attempts to Remedy It Megan O'Reilly Follow this and additional works at: https://via.library.depaul.edu/jhcl Recommended Citation Megan O'Reilly, Failures of Project BioShield & Congressional Attempts to Remedy It, 10 DePaul J. Health Care L. 503 (2007) Available at: https://via.library.depaul.edu/jhcl/vol10/iss3/8 This Case Briefs is brought to you for free and open access by the College of Law at Via Sapientiae. It has been accepted for inclusion in DePaul Journal of Health Care Law by an authorized editor of Via Sapientiae. For more information, please contact [email protected]. CASE BRIEF: THE FAILURES OF PROJECT BIOSHIELD & CONGRESSIONAL ATTEMPTS TO REMEDY IT Megan O'Reilly I. THE THREAT OF A BIOLOGICAL TERROR ATTACK In response to the 2001 terrorist attacks, the United States government began a crash program to develop drugs, vaccine and diagnostic tests to protect the nation from biological terrorism.' As part of this effort, President Bush signed Project BioShield into law on July 21, 2004. The legislation was intended to facilitate a faster process to research, develop, purchase and make bioterrorism countermeasures available to combat bioterrorist threats. 2 However, Project BioShield is not drawing the interest it aimed for. The legislation has faced significant criticism because the law has failed to adequately provide consistent and well-coordinated financing, and sufficient, ensured markets, as well as any liability protection for vaccine developers. 3 The threat of a biological attack is very real.4 To ensure that Project BioShield assists in protecting the nation from future bioterrorist attacks, it is necessary to evaluate the successes and setbacks the initiative has faced.
    [Show full text]
  • Public Law 108–276 108Th Congress An
    PUBLIC LAW 108–276—JULY 21, 2004 118 STAT. 835 Public Law 108–276 108th Congress An Act To amend the Public Health Service Act to provide protections and countermeasures against chemical, radiological, or nuclear agents that may be used in a terrorist attack against the United States by giving the National Institutes of Health July 21, 2004 contracting flexibility, infrastructure improvements, and expediting the scientific [S. 15] peer review process, and streamlining the Food and Drug Administration approval process of countermeasures. Be it enacted by the Senate and House of Representatives of the United States of America in Congress assembled, Project BioShield Act of 2004. SECTION 1. SHORT TITLE. 42 USC 201 note. This Act may be cited as the ‘‘Project BioShield Act of 2004’’. SEC. 2. BIOMEDICAL COUNTERMEASURE RESEARCH AND DEVELOP- MENT—AUTHORITIES. (a) IN GENERAL.—Part B of title III of the Public Health Service Act (42 U.S.C. 243 et seq.) is amended by inserting after section 319F the following section: ‘‘SEC. 319F–1. AUTHORITY FOR USE OF CERTAIN PROCEDURES 42 USC 247d–6a. REGARDING QUALIFIED COUNTERMEASURE RESEARCH AND DEVELOPMENT ACTIVITIES. ‘‘(a) IN GENERAL.— ‘‘(1) AUTHORITY.—In conducting and supporting research and development activities regarding countermeasures under section 319F(h), the Secretary may conduct and support such activities in accordance with this section and, in consultation with the Director of the National Institutes of Health, as part of the program under section 446, if the activities concern qualified countermeasures. ‘‘(2) QUALIFIED COUNTERMEASURE.—For purposes of this section, the term ‘qualified countermeasure’ means a drug (as that term is defined by section 201(g)(1) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
    [Show full text]
  • Can Bioshield Effectively Procure Medical
    CAN BIOSHIELD EFFECTIVELY PROCURE MEDICAL COUNTERMEASURES THAT SAFEGUARD THE NATION? HEARING BEFORE THE SUBCOMMITTEE ON EMERGING THREATS, CYBERSECURITY AND SCIENCE AND TECHNOLOGY OF THE COMMITTEE ON HOMELAND SECURITY HOUSE OF REPRESENTATIVES ONE HUNDRED TENTH CONGRESS FIRST SESSION APRIL 18, 2007 Serial No. 110–23 Printed for the use of the Committee on Homeland Security Available via the World Wide Web: http://www.gpoaccess.gov/congress/index.html U.S. GOVERNMENT PRINTING OFFICE 43–559 PDF WASHINGTON : 2009 For sale by the Superintendent of Documents, U.S. Government Printing Office Internet: bookstore.gpo.gov Phone: toll free (866) 512–1800; DC area (202) 512–1800 Fax: (202) 512–2104 Mail: Stop IDCC, Washington, DC 20402–0001 VerDate Nov 24 2008 10:52 Jun 11, 2009 Jkt 000000 PO 00000 Frm 00001 Fmt 5011 Sfmt 5011 H:\DOCS\110-HRGS\110-23\43559.TXT HSEC PsN: DIANE Congress.#13 COMMITTEE ON HOMELAND SECURITY BENNIE G. THOMPSON, Mississippi, Chairman LORETTA SANCHEZ, California, PETER T. KING, New York EDWARD J. MARKEY, Massachusetts LAMAR SMITH, Texas NORMAN D. DICKS, Washington CHRISTOPHER SHAYS, Connecticut JANE HARMAN, California MARK E. SOUDER, Indiana PETER A. DEFAZIO, Oregon TOM DAVIS, Virginia NITA M. LOWEY, New York DANIEL E. LUNGREN, California ELEANOR HOLMES NORTON, District of MIKE ROGERS, Alabama Columbia BOBBY JINDAL, Louisiana ZOE LOFGREN, California DAVID G. REICHERT, Washington SHEILA JACKSON LEE, Texas MICHAEL T. MCCAUL, Texas DONNA M. CHRISTENSEN, U.S. Virgin CHARLES W. DENT, Pennsylvania Islands GINNY BROWN-WAITE, Florida BOB ETHERIDGE, North Carolina MARSHA BLACKBURN, Tennessee JAMES R. LANGEVIN, Rhode Island GUS M. BILIRAKIS, Florida HENRY CUELLAR, Texas DAVID DAVIS, Tennessee CHRISTOPHER P.
    [Show full text]
  • Material Threat Assessment
    BiologicalBiologicalLarryLarry Kerr,Kerr, ThreatThreat Ph.D.Ph.D. Agents:Agents: DeterminationDetermination andand ImplicationImplication forfor LifeLife OfficeOfficeSciencesSciences ofof ScienceScience ResearchResearch andand TechnologyTechnologyLarry Kerr, Ph.D.PolicyPolicy AssistantAssistantAssistant DirectorDirectorDirector for Homeland forfor HomelandHomeland Security Office of ScienceSecuritySecurity and Technology Policy Executive Office of the President MIT Security Studies Program MIT Faculty Club Cambridge, MA March 7, 2005 Comprehensive WMD Preparedness Strategy W MD PRE-EVENT E POST-EVENT VE NT PREVENTION PROTECTION SURVEILLANCE RESPONSE AND RECOVERY AND DETECTION RESEARCH, DEVELOPMENT AND ACQUISITION Investment Review and Prioritization THREAT ASSESSMENT AND AWARENESS Domestic & International INFORMATION MANAGEMENT AND COMMUNICATIONS FUTURE THREAT INITIATIVE Pillars of our Biodefense Program Information Management&Communications Creation andMaintenanceofInfrastructure Strengthened InternationalCooperation Research, Development andAcquisition Research, Development Biothreat Biothreat Plum IslandAnimalDiseaseCenter Plum IslandAnimalDiseaseCenter Testing andEvaluationCenter Biodefense Biodefense Testing andEvaluationCenter Bioforensic BiodefenseTHREAT Bioforensic AWARENESS Bio Characterization Bio Public Preparedness Assessment SupportCenter Assessment SupportCenter - - Countermeasures Countermeasures PREVENTION Knowledge Center Knowledge Center Analysis Center BioforensicsPROTECTION Analysis Center SURVEILLANCEAgrobio- terrorismDETECTION
    [Show full text]
  • DTIC) Computer- Generated Bibliography Prepared by Matching the Subject Terms: Epidemic, Coronavirus, Pandemic Against the Technical Report Database, 2020
    Description of document: Defense Technical Information Center (DTIC) computer- generated bibliography prepared by matching the subject terms: epidemic, coronavirus, pandemic against the Technical Report database, 2020 Requested date: 12-April-2020 Release date: 19-May-2020 Posted date: 01-June-2020 Source of document: Defense Technical Information Center (DTIC-R) ATTN: FOIA Requester Service Center 8725 John J. Kingman Road Fort Belvoir, Virginia 22060-6218 Fax: 703-767-9201 Email Form Contact DTIC FOIA The governmentattic.org web site (“the site”) is a First Amendment free speech web site, and is noncommercial and free to the public. The site and materials made available on the site, such as this file, are for reference only. The governmentattic.org web site and its principals have made every effort to make this information as complete and as accurate as possible, however, there may be mistakes and omissions, both typographical and in content. The governmentattic.org web site and its principals shall have neither liability nor responsibility to any person or entity with respect to any loss or damage caused, or alleged to have been caused, directly or indirectly, by the information provided on the governmentattic.org web site or in this file. The public records published on the site were obtained from government agencies using proper legal channels. Each document is identified as to the source. Any concerns about the contents of the site should be directed to the agency originating the document in question. GovernmentAttic.org is not responsible for the contents of documents published on the website. DEFENSE TECHNICAL INFORMATION CENTER 8725 JOHN J.
    [Show full text]
  • The Project Bioshield Act: Issues for the 112Th Congress
    The Project BioShield Act: Issues for the 112th Congress Frank Gottron Specialist in Science and Technology Policy February 8, 2012 Congressional Research Service 7-5700 www.crs.gov R42349 CRS Report for Congress Prepared for Members and Committees of Congress The Project BioShield Act: Issues for the 112th Congress Summary In 2004, Congress passed the Project BioShield Act (P.L. 108-276) to provide the federal government with new authorities related to the development, procurement, and use of medical countermeasures against chemical, biological, radiological, and nuclear (CBRN) terrorism agents. As the expiration of some of these authorities approaches, Congress is considering whether these authorities have sufficiently contributed to national preparedness to merit extension. The Project BioShield Act provides three main authorities: (1) guaranteeing a federal market for new CBRN medical countermeasures, (2) permitting emergency use of countermeasures that are either unapproved or have not been approved for the intended emergency use, and (3) relaxing regulatory requirements for some CBRN terrorism-related spending. The Department of Health and Human Services (HHS) has used each of these authorities. The HHS obligated approximately $2.5 billion to guarantee a government market for countermeasures against anthrax, botulism, radiation, and smallpox. The HHS allowed the emergency use of several unapproved products, including during the 2009 H1N1 influenza pandemic. The HHS used expedited review authorities to approve contracts and grants related to CBRN countermeasure research and development. The Department of Homeland Security (DHS) Appropriations Act, 2004 (P.L. 108-90) advance- appropriated $5.593 billion to acquire CBRN countermeasures through Project BioShield for FY2004-FY2013. Through FY2012, subsequent Congresses have removed $1.876 billion from this account through rescissions and transfers, more than one-third of the advance appropriation.
    [Show full text]
  • BIODEFENSE Federal Efforts to Develop Biological Threat Awareness
    United States Government Accountability Office Report to Congressional Requesters October 2017 BIODEFENSE Federal Efforts to Develop Biological Threat Awareness GAO-18-155 October 2017 BIODEFENSE Federal Efforts to Develop Biological Threat Awareness Highlights of GAO-18-155, a report to congressional requesters Why GAO Did This Study What GAO Found Biological threats come from a variety Key biodefense agencies—the Departments of Homeland Security (DHS), of sources and can pose a catastrophic Defense (DOD), Agriculture (USDA), and Health and Human Services (HHS), danger to public health, animal and and the Environmental Protection Agency—conduct a wide range of activities to plant health, and national security. develop biological threat awareness for intentional and naturally occurring Threat awareness, which consists of threats, and reported using that information to support investment decisions. activities such as collecting and analyzing intelligence, developing risk • Intelligence gathering: Agencies use a combination of intelligence assessments, and anticipating future gathering on adversaries’ capabilities to cause harm with a biological weapon threats, is vital to help federal agencies and global disease surveillance to monitor threats from naturally occurring identify necessary biodefense health threats that might impact humans, animals, or plants. capabilities and ensure investments • Scientific research: Agencies use traditional laboratory research to help are prioritized to make effective use of understand the characteristics
    [Show full text]